Fixed-Dose Combinations for Treatment of Type 2 Diabetes Mellitus

Blonde, Lawrence; Juan, Zinnia T. San

doi:10.1007/s12325-011-0094-1

Cited by 53 publications

(37 citation statements)

References 41 publications

(15 reference statements)

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“…24,26,28,30,32 PeRC considered that compliance with medications is an issue particularly in adolescents and, therefore, a combination product would potentially be advantageous. 35,36 …”

Section: Resultsmentioning

confidence: 99%

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007–2013

Egger¹,

Wharton

Malli

et al. 2016

Ther Innov Regul Sci

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Background The European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods This is a retrospective review comparing EMA’s Paediatric Committee (PDCO) decisions with FDA’s Pediatric Review Committee (PeRC) recommendations for all product-specific pediatric full waiver applications submitted to EMA from January 2007 through December 2013. Using baseline data from EMA, we matched product-specific waivers with their FDA equivalents during the study period. Results For single active substance products, PDCO and PeRC adopted similar opinions in 42 of 49 indications (86%). For fixed-dose combinations, PDCO and PeRC adopted similar opinions in 24 of 31 indications (77%). Conclusion Despite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases.

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“…24,26,28,30,32 PeRC considered that compliance with medications is an issue particularly in adolescents and, therefore, a combination product would potentially be advantageous. 35,36 …”

Section: Resultsmentioning

confidence: 99%

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007–2013

Egger¹,

Wharton

Malli

et al. 2016

Ther Innov Regul Sci

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“…In addition, we did not consider a dose increase within the same drug class as a form of therapy intensification, and intensification was defined as only an add‐on, which precludes the distinction of an actual intensification from a treatment switch, all of which might have led to an overestimation of therapeutic inertia. Similarly, we considered fixed‐dose combinations as 2 different NIADs, but they have been reported to be associated with greater adherence compared to the combination of separate pills, which may impact the need for treatment intensification in some cases. Moreover, differences between general practitioners and endocrinologists must be taken into account, as specialists are more likely to use insulin therapies (eg, in 8.6% and 1.7%, respectively, of patients with poor glycaemic control) and they tend to initiate insulin treatment sooner than primary care physicians .…”

Section: Discussionmentioning

confidence: 99%

Therapeutic inertia in patients treated with two or more antidiabetics in primary care: Factors predicting intensification of treatment

Mata-Cases

Franch-Nadal

Real

et al. 2017

Diabetes Obesity Metabolism

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“…81 Importantly, single-pill FDCs may offer cost advantages over multiple-pill combinations. 75,76,80,82 A recent retrospective, real-world study using claims data from 1 January 2009 to 31 December 2013 analysed health economic outcomes in 23 361 patients with T2D.…”

Section: Fixed-dose Combinationsmentioning

confidence: 99%

Initiating therapy in patients newly diagnosed with type 2 diabetes: Combination therapy vs a stepwise approach

Cersósimo

Johnson

Chovanes³

et al. 2017

Diabetes Obesity Metabolism

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There is clear evidence that achieving glycaemic targets reduces the risk of developing complications as a result of type 2 diabetes (T2D). Many patients, however, continue to have suboptimal glycaemic control because of issues that include unclear advice on how to achieve these targets as well as clinical inertia. The two management approaches recommended for patients newly diagnosed with T2D are stepwise and combination therapy, each of which has advantages and disadvantages. Stepwise therapy may result in good patient adherence and allow greater individualization of therapy, and minimization of side effects and cost, and so may be appropriate for patients who are closer to goal. Stepwise therapy, however, may also lead to frequent delays in achieving glycaemic goals and longer exposure to hyperglycaemia. Combination therapy, which is now emerging as an important therapy option, has a number of potential advantages over stepwise therapy, including reduction in clinical inertia and earlier and more frequent achievement of glycated haemoglobin goals by targeting multiple pathogenic mechanisms simultaneously, which may more effectively delay disease progression. Compared with stepwise therapy, the disadvantages of combination therapy include reduced patient adherence resulting from complex, multi-drug regimens, difficulty determining the cause of poor efficacy and/or side effects, patient refusal to accept disease, and higher cost. Fixed-dose and fixed-ratio combinations are novel therapeutic approaches which may help address several issues of treatment complexity and patient burden associated with combination therapy comprising individual drugs. The choice of which drugs to administer and the decision to use stepwise vs combination therapy, however, should always be made on an individualized basis.

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Fixed-Dose Combinations for Treatment of Type 2 Diabetes Mellitus

Cited by 53 publications

References 41 publications

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007–2013

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007–2013

Therapeutic inertia in patients treated with two or more antidiabetics in primary care: Factors predicting intensification of treatment

Initiating therapy in patients newly diagnosed with type 2 diabetes: Combination therapy vs a stepwise approach

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